Manufacturer

Busse Hospital Disposables, Inc.

63 recalls in our database name Busse Hospital Disposables, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–63 of 63

ModerateFDA (Devices)·Z-1191-2022·2022-06-08
Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing. The affected products include lot numbers 2110053 and 2110115, representing 60 units distributed nationwide.
Product
SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1181-2022·2022-06-08
Medical swab insertion tray recalled due to manufacturing validation uncertainty
Busse Hospital Disposables recalls swab insertion trays due to uncertainty about manufacturing test method validation. The Class II recall affects products nationwide.
Product
SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1150-2022·2022-06-08
Lumbar Tray with Swab Products Recalled Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling Lumbar Tray units nationwide because test methods used during manufacturing could not be adequately validated. The recall affects swab/swabstick products used in medical procedures.
Product
Lumbar Tray Catalog 1091
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1164-2022·2022-06-08
Busse Convenience Kits Swabs Recalled Due to Testing Validation Uncertainty
Busse Hospital Disposables is recalling Busse Convenience Kits containing medical swabs and swabsticks due to uncertainty about test method validation in manufacturing. No illnesses reported.
Product
Pain Tray Catalog Number: 9883
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1159-2022·2022-06-08
Single Shot Epidural Tray Recalled Due to Test Validation Uncertainty
Single Shot Epidural Trays made by Busse Hospital Disposables are being recalled nationwide due to inadequate validation of the test methods used to manufacture the product. The recall affects 400 units.
Product
Single Shot Epidural Tray Catalog Number: 8417
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1168-2022·2022-06-08
Cervical Tray Recalled for Manufacturing Test Method Validation Uncertainty
Busse Hospital Disposables is recalling Cervical Tray Catalog Number 3765R2 units containing swab products due to uncertainty about the adequacy of manufacturing test method validation. Lot Numbers 2031213S and 2130221S are affected.
Product
Cervical Tray Catalog Number: 3765R2
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1151-2022·2022-06-08
Busse Hospital Epidural Trays Recalled for Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling Single Shot Epidural Trays due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
Product
Single Shot Epidural Tray Catalog 1165
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1197-2022·2022-06-08
Drug Swab Products Recalled for Manufacturing Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products made by PDI are being recalled due to uncertainty about validation testing adequacy in manufacturing. Users should discontinue use of affected lot numbers.
Product
3.2MM Pellet Insertion Tray Catalog Number: B7345R1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1147-2022·2022-06-08
I.V. Start Kit with Swab Products Recalled for Manufacturing Validation Issues
Busse Hospital Disposables is recalling I.V. Start Kits containing swab products due to inadequate validation of manufacturing test methods. Approximately 2,475 units nationwide may be affected.
Product
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1180-2022·2022-06-08
Swab and Swabstick Drug Products Recalled Due to Validation Uncertainty
Busse Convenience kits with swab and swabstick drug products are being recalled because the validation of the test methods used during manufacturing is uncertain.
Product
"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1193-2022·2022-06-08
Busse Convenience Kit Swab Products Recalled for Test Method Validation Issues
Busse Convenience kits containing swab and swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing.
Product
SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1195-2022·2022-06-08
Convenience Kits with Drug Swab Products Recalled for Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products are being recalled nationwide due to uncertainty about the adequacy of the validation of manufacturing test methods.
Product
Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1184-2022·2022-06-08
Pellet Insertion Tray Recall for Uncertain Manufacturing Test Validation
Busse Hospital Disposables is recalling SS 3.5MM Pellet Insertion Tray kits nationwide. The kits contain swab products with uncertain manufacturing test method validation.
Product
SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
Category
Medical Device
Distribution
Distributed nationwide